JCO Exclusive: In Pediatric Phase I Trials, Hope Is Emphasized over Realism

Sep 15, 2014

             
        Key Points
 
  • The study found that for every one “realistic” statement doctors made during informed consent conferences (ICCs), they made three hopeful statements indicating that the treatment could bring about positive outcomes, such as lengthening the life of the child.
  • The study also found that in 68% of the ICCs, doctors failed to mention that parents could opt for no treatment or palliative care for their child. In 85% of ICCs, doctors did not mention that the disease was incurable.
   
             

By Shira Klapper, Senior Writer/Editor

When doctors present clinical trials to patients with advanced cancer during informed consent conferences (ICCs), they have to balance messages of hope and realism—describing both the promising potential of the new treatment, as well as the likelihood that hospice and end-of-life care will be necessary. Striking the right balance becomes especially important when presenting phase I trials, which are not designed to halt the progression of the cancer or to bring about a remission in disease, but to test the safety of the new treatment and determine proper dose.

A new Journal of Clinical Oncology (JCO) study, funded by National Institutes of Health, describes the work of researchers who sought a better understanding of how doctors balance hope and realism during a uniquely challenging ICC—that between doctors and parents of children with cancer. This kind of ICC is often fraught because doctors may find it difficult to discuss the death of a child with parents, leading them to stress a message of hope over realism. To find out exactly what was being said and discussed in these ICCs, the research team used audio recordings of the actual discussions and then analyzed the transcripts.

The study, “Hope and Persuasion during Informed Consent,” published online, ahead of print September 8, found that during ICCs, doctors may not be striking a balance between messages of hope and realism. Among the important findings was that for every one “realistic” statement doctors made, they made three hopeful statements indicating that the treatment could bring positive outcomes, such as lengthening the life of the child. The study also found that in 68% of the ICCs, doctors failed to mention that parents could opt for no treatment or palliative care for their child. In 85% of ICCs, doctors did not mention that the disease was incurable.

 
Eric Kodish, MD   

“From a normative ethics perspective, I think palliative care or no treatment should be mentioned in every Phase I ICC,” said the study’s senior author Eric Kodish, MD. “Only 15% of the cases included a statement about the disease being incurable. But, we know that in all of these cases, the disease was incurable, and 85% of doctors did not mention that.” Nearly all of the 85 children who participated in this study have subsequently died, living on average a little less than a year from the time of the consent process.

The study also looked at how frequently the doctors used language of “persuasion” and its opposite, language designed to “alleviate pressure.” Persuasion was defined as statements that stressed the urgency of enrolling, the good to society, and the like. “Alleviate pressure” was defined as comments indicating that enrolling is optional, and no one would be angry if parents opted out. The study found that the ratio of “persuasion” to “alleviate pressure” statements during the ICCs was 0.88, which according to Dr. Kodish, means that, “There’s a nice balance between statements to pressure people into being in the study and statements to alleviate pressure. It does not look like coercion is a problem here.”

The difficult task of breaking bad news

In explaining why doctors might overemphasize hope and downplay realistic outcomes, Dr. Kodish pointed to the psychologically delicate and complex nature of the ICC encounter.

“Doctors are human, and they want to bring hope to children and parents,” said Dr. Kodish. “And parents are looking to do whatever they can to extend the life of their child, so it’s kind of a perfect storm in that sense.”

But, according to Dr. Kodish, the reality is that most of the children in phase I studies will die of their disease. And less-than-optimal or suboptimal communication about the prognosis may not only limit parents’ ability to provide high-quality informed consent, but might also delay their decision to enroll their child in hospice or palliative care during the last weeks and months of his or her life, preventing the child from receiving the clinical benefit offered by these approaches.

Dr. Kodish stressed that this study was not meant to question the ethical acceptability of phase I studies themselves.

“It’s really important to stress that, in this study, we’re not saying that phase I studies in children are unethical. They are in fact ethically praiseworthy because they help future children. It is how we communicate about phase I studies and how informed consent happens that is so important.”


Eric Kodish, MD, is the Director of Cleveland Clinic's Center for Ethics, Humanities, and Spiritual Care, the F. J. O'Neill Professor and Chairman of the Department of Bioethics, Executive Director of the Cleveland Fellowship in Advanced Bioethics, and Professor of Pediatrics at the Lerner College of Medicine of Case Western Reserve University.


 Source

 


Click here to read the abstract.

 


Click here to read the PDF.

 

Miller VA, Cousino M, Leek AC. Hope and persuasion by physicians during informed consent. J Clin Oncol. Epub 2014 Sep 8.

The Exclusive Coverage series on ASCO.org highlights selected research from JCO and JOP with additional perspective provided by the lead or corresponding author.

 

@ 2014 American Society of Clinical Oncology

 

 

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